Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02681874 |
| Other study ID # |
H-37460 |
| Secondary ID |
46486-I |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2015 |
| Est. completion date |
April 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Baylor College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Many behavioral interventions designed to improve dietary patterns for ethnic and
racial/minority preschoolers have produced modest outcomes. A limitation of these
interventions include a failure to address key factors associated with dietary patterns for
these children, such as parental stress levels. Therefore, the identification of intervention
models that target these factors and are effective, acceptable, and feasible among parents of
young minority children is important.
Subjects will be asked to take part in this study because they are the parents of a child
that receives care at a Texas Children's Pediatrics (TCP) clinic where the study is being
done and their child's body mass index has been at or above the 85th percentile.
The purpose of this pilot study is to assess the ease and acceptance of providing an
intervention for parents of children ages 2-5 years in the pediatric primary care clinic. The
purpose is to also assess how well the intervention works in improving the child's dietary
patterns.
Description:
Thirty (30) subjects will be enrolled across three (3) TCP clinics where the study will take
place. Two types of participants will be recruited for this study: parent participants who
will receive the intervention and interventionist participants who will deliver the
intervention.
Data collected for this study includes 4 types: parent-report questionnaires, parent saliva
samples, parent-report of children's 24-hour food recall, and audio-recordings of
intervention sessions. Parent-report questionnaires will assess family demographic
information, parental stress, depression, and well-being as well as parental feeding
practices and child dietary food patterns.
Procedures for Parent Participants:
Parents will be randomized to the intervention (Group A-15 parents) or control condition
(Group B-15 parents). Parents who are randomized to the intervention group will then
participate in the 10-session SSC program that is co-led by a trained parent interventionist.
Sessions will be audio-recorded to allow intervention fidelity checks. Parents who are
randomized to the control condition will receive the SSC written handouts, which is enhanced
standard of care for parents who are seen in primary care.
If subjects are assigned to Group A, they will participate in ten intervention sessions that
are conducted in the TCP clinic. During each session, subjects will be provided with
information about specific skills to improve their child's emotional health and dietary
patterns and their own stress levels.
If subjects are assigned to Group B, they will receive written handouts about children's
dietary patterns and parent stress levels. They will be instructed to write goals and
document goal progress. This care plan is the standard practice and is presently implemented
in the site's TCP clinics.
After ten weeks, regardless of the group the subjects were assigned to, they will again
complete an interview about their child's dietary food patterns and questionnaires about
their own emotions/opinions of their parenting and child feeding practices. The subjects will
also be asked to collect their saliva at four time points on a single day at home.
Procedures for Interventionist Participants:
Six interventionist participants will be recruited. Those who indicate interest will meet
with the PI or a research staff member to obtain consent. They will then receive 40-hours of
training in the intervention provided by study staff. Intervention participants will deliver
one or more group intervention, which has 10 sessions.
